Systems and methods for soft tissue reconstruction

ABSTRACT

Suture-based fasteners and fastening methods for soft tissue reconstruction are described that can include a needle tip swaged onto two sutures and loaded onto the end of a curved needle shaft. The needle shaft and tip can be driven through the tissues to be sutured and back out to where the needle tip can make a permanent connection with a locking bead. The needle shaft can be retracted, leaving two sutures extending from the side of the bead. One suture can be of nonabsorbable material and can be brought through the end of the locking bead opposite the tip and pulled to tighten the suture loop. The other suture can be of an absorbable material and can be used to rotate the locking bead under one of the layers of tissue being sutured after the suture loop is tightened. Following rotation, the second suture can be trimmed.

CROSS-REFERENCE TO RELATED APPLICATIONS

This application is a continuation of U.S. application Ser. No.10/740,132, filed Dec. 18, 2003, now U.S. Pat. No. 7,338,502, whichclaims the benefit of U.S. Provisional Application No. 60/434,740, filedon Dec. 18, 2002. The aforementioned patent applications are herebyincorporated herein by reference.

TECHNICAL FIELD

The invention relates generally to the use of soft tissue fixationdevices and application instruments and accessories used inreconstructive soft tissue surgery.

BACKGROUND OF THE INVENTION

Surgical procedures often involve the apposition of tissues with the useof sutures or other devices, such as metallic clips or staples.Reconstructive surgical procedures depend on the permanent approximationof tissues, usually with the use of nonabsorbable suture material. Inpelvic reconstructive surgery, for example, several approaches arecommonly used to treat various types of pelvic support defects,including cystocele, rectocele, enterocele, uterine prolapse or vaginalvault prolapse after hysterectomy. Abdominal or laparoscopic surgery maybe used to elevate the urethra or bladder, the uterus or vaginal vault.Sutures may be placed under the vaginal epithelium in order to suspendthe vagina to supporting structures, such as the pelvic side wall, thearcus tendineous fascia pelvis, the sacrospinous ligament, Uterosacralligament, Cooper's ligament, the pubic symphysis or the anteriorlongitudinal ligament of the sacral promontory. Vaginal reconstructivesurgery may utilize some of the same supporting structures, although thevaginal wall must be opened either anteriorly, posteriorly or apically,in order to place the suspending sutures under the vaginal epithelium.Although vaginal surgery is associated with decreased morbidity, lengthof stay and recovery compared with abdominal surgery, there is evidencethat it may lead to greater denervation and increased rates of recurrentprolapse and need for reoperation. There exists a need in reconstructiveand other types of surgery to create a system whereby tissues may beapproximated in a minimally-invasive and automated fashion.

SUMMARY OF THE INVENTION

Fasteners may be designed to recreate the basic concept of sutures,which may appeal to surgeons who feel more comfortable with standardsuturing techniques for surgery, including pelvic reconstructivesurgery. For example, transvaginal surgery including paravaginalcystocele repair may be performed without the need for a mucosalincision. It is desirable to avoid having a knot within the vaginallumen. After the area of the arcus tendineous fascia pelvis is palpatedvaginally between the posterior-lateral aspect of the pubic bone and theischial spine, a series of fasteners may be placed along the arcustendineous fascia pelvis, reapproximating the vaginal wall to the pelvicsidewall and reestablishing the position of the lateral vaginal sulci.Having a tight suture loop without a knot in the vagina may promotereepithelialization, whereas the presence of a suture knot may preventthe vaginal mucosa from healing over the suture. In the presentinvention, suture-based fasteners are described that, when deployed,result in a knot-free, tight suture loop. In transvaginal reconstructivesurgery, for example, this configuration may promote reepithelializationof suture material in the vaginal lumen.

In one embodiment, a method of connecting a first layer of tissue and asecond layer of tissue can include providing a loop in a suture to forma loop end, driving the loop end and/or a combination of the loop endand an end of the suture on a path through the first layer, into thesecond layer, and back through the first layer, engaging the loop endwith an engaging mechanism located proximate the end of the suture toform a closed ring, tightening the closed ring by drawing the loop endback along the path, and rotating the ring to place the engagingmechanism within the second layer.

In one embodiment, a system for connecting a first layer of tissue and asecond layer of tissue can include a suture, a loop in the suture toform a loop end of the suture, means for driving at least one of theloop end and a combination of the loop end and an end of the suture on apath through the first layer, into the second layer, and back throughthe first layer, engaging means proximate the end of the suture engagingthe loop end to form a closed ring, means for tightening the closed ringby drawing the loop end back along the path, and means for rotating thering to place the engaging means within the second layer.

BRIEF DESCRIPTION OF THE DRAWINGS

FIGS. 1A-1C illustrate tissue undergoing reconstruction using oneembodiment of a fastener having an engaging mechanism for tightening thesuture;

FIGS. 2A-2B illustrate tissue undergoing reconstruction using oneembodiment of a fastener having an engaging mechanism and a separatesuture-tightening mechanism;

FIGS. 3A-3B illustrate tissue undergoing reconstruction using oneembodiment of a fastener having an engaging mechanism and a separatesuture-tightening mechanism being both driven into the tissue;

FIGS. 4A-4E illustrate tissue undergoing reconstruction using oneembodiment of a fastener having mechanism for pulling a suture throughthe tissue; and

FIGS. 5A-5B illustrate tissue undergoing reconstruction using oneembodiment of a fastener having an engaging mechanism formed from thesuture.

DETAILED DESCRIPTION OF THE INVENTION

To provide an overall understanding, certain illustrative embodimentswill now be described; however, it will be understood by one of ordinaryskill in the art that the systems and methods described herein can beadapted and modified to provide systems and methods for other suitableapplications and that other additions and modifications can be madewithout departing from the scope of the systems and methods describedherein.

Unless otherwise specified, the illustrated embodiments can beunderstood as providing exemplary features of varying detail of certainembodiments, and therefore, unless otherwise specified, features,components, modules, and/or aspects of the illustrations can beotherwise combined, separated, interchanged, and/or rearranged withoutdeparting from the disclosed systems or methods. Additionally, theshapes and sizes of components are also exemplary and unless otherwisespecified, can be altered without affecting the disclosed systems ormethods.

The invention will now be described with reference to certainillustrated embodiments and certain exemplary practices. Specifically,the invention will be described hereinafter in connection with softtissue reconstructive medical procedures, described in more detailbelow, and with urogynecological reconstruction. As used herein, theinvention can be used to connect two layers of tissue, which can bereferred to herein as a pelvic sidewall, vaginal lumen, vaginal mucosa,or other similar tissues. However, it should be understood that thefollowing description is only meant to be illustrative of the inventionand is not meant to limit the scope of the invention, which isapplicable to other forms of soft tissue reconstruction, as will beevident to practitioners in the art.

In certain embodiments, the common theme is to create a knot or othertype of attachment of two ends of a suture and then to rotate the “knot”under the mucosa, so that only a tight suture loop remains in thevaginal lumen.

In one embodiment 10 (FIGS. 1A-1C), a needle tip 12 is swaged on to twosutures, 14A, 14B which are loaded in a hand-held instrument 16. Theneedle tip is loaded on to the end of a curved needle shaft 18, in amanner similar to a Capio needle driver. Pushing a piston-type button(not shown) drives the needle shaft with pre-loaded needle tip throughthe tissue and back into the instrument, where the needle tip makes apermanent connection with a locking bead 20, which has a female end 20A,in which the needle tip will connect (FIG. 1B). The needle shaft is thenretracted back into the instrument. There are two sutures that come outfrom the side of the bead where the male and female ends are connected,sutures 14A and 14B. Suture 14A is engaged with the other end of thelocking bead 20B, which is made of either a plastic or metal material.This suture segment may be of nonabsorbable material. The end of suture14A is pulled after the connection is made between the needle tip andthe locking bead, in order to tighten the suture loop, which recreatesthe tightness of a standard suture loop. The other suture 14B is used torotate the locking bead under the vaginal mucosa after the connectionbetween the needle tip and locking bead is made, and after the sutureloop is tightened (FIG. 1C). Following this rotation of the lockingbead, the second suture must be trimmed under the vaginal mucosa. Thissecond suture may be made of absorbable material.

In another embodiment 50 (FIGS. 2A-2B), the needle tip 52 (which ispushed through the tissue with a retractable needle shaft, as in theCapio needle driver) has an attached suture tightening mechanism 54,similar to the mechanism used to tighten a backpack strap. When theneedle is driven through the tissue, the tip connects to the femalelocking bead 56, which is attached to one end 58A of the suture 58 (FIG.2A). The locking bead is located and held in position in the instrument.Pulling on the other end 58B of the suture 58 initially tightens thesuture loop, and then rotates the locking bead under the vaginal mucosa(FIG. 2B). The instrument may have a mechanism that holds the lockingbead in place during the tightening process, and then releases thelocking bead so that it may rotate under the mucosa. The holdingmechanism may release the locking bead when a predetermined tension isattained, or may be manually released by the surgeon after the suture istightened. The suture is then trimmed under the vaginal mucosa. This isaccomplished with a cutting blade located within the instrument and cutsthe suture even with the most distal portion of the instrument.

In another embodiment 70 (FIGS. 3A-3B), the connection between the male(needle tip 72) and female (locking bead 74) ends is made within thepelvic sidewall. This is done by pushing a button (not shown) on the endof the instrument 76, which deploys the two hollow needle shafts 78A,78B. The needle shafts pierce the vaginal wall and meet under the pelvicsidewall, which automatically locks the male and female ends together(FIG. 3A). By releasing the button, the needle shafts are retracted,leaving the connection within the tissue (FIG. 3B). After the connectionis made, the suture 80 that comes out through the female portion of thebead, or cleat 82, is pulled, which tightens the suture loop 80A. Thesuture is then trimmed under the vaginal mucosa. This is accomplishedwith a cutting blade (not shown) located within the instrument and cutsthe suture even with the most distal portion of the instrument.

In another embodiment 100 (FIGS. 4A-4E), pushing a piston-like button(not shown) on the proximal end of the instrument 102 pushes a notchedcurved needle 104 located at the distal end of the instrument throughthe pelvic sidewall (FIG. 4A) and upon exiting the tissue, a loop 106Aof suture 106 located in the distal instrument is captured by the notch104A of the needle and pulled back through the tissue (FIG. 4B) and backinto the instrument. One end of this suture loop is then brought througha locking cleat 110, which is attached to one end 106B of the suture 106(FIG. 4C). This locking cleat may be metallic or plastic and is held inplace in the distal end of the instrument. Although it may take one of anumber of configurations, the basic concept of the cleat is that itcaptures a strand of suture, and pulling on the other end 106C of thesuture loop (which resides within the instrument) makes the knotencompassing the tissue tighter and tighter (FIG. 4D). Once apredetermined suture tension is attained, or when the surgeon determinesthat the tension is appropriate by other means, the cleat is released bythe instruments, which then permits rotation of the locking cleat underthe vaginal mucosa or lumen (FIG. 4E). The suture is then trimmed underthe vaginal mucosa. This is accomplished with a cutting blade locatedwithin the instrument and cuts the suture even with the most distalportion of the instrument.

In another embodiment 120 (FIGS. 5A-5B), a hollow needle shaft (notshown) (similar to a Capio needle driver) is used to carry a pre-loadedneedle tip 122 with a single swaged suture 124 through a preformed open“hitch” knot 126 connected to an end 124A of suture 124 opposite theneedle tip on the other side of the instrument (not shown). The needletip then makes a connection with a female element (not shown) within theinstrument. A mechanism (not shown) that pulls back on the femaleelement (after connection is made with the needle tip) tightens thehitch knot. The suture on the needle tip is cut near the preformed knotand a second suture 128, attached at a point 124B to the primary suture124, is used to rotate the knot under the vaginal mucosa or lumen. Thesecond suture is then trimmed under the vaginal mucosa. This isaccomplished with a cutting blade located within the instrument and cutsthe suture even with the most distal portion of the instrument.

Unless otherwise stated, use of the word “substantially” can beconstrued to include a precise relationship, condition, arrangement,orientation, and/or other characteristic, and deviations thereof asunderstood by one of ordinary skill in the art, to the extent that suchdeviations do not materially affect the disclosed methods and systems.Throughout the entirety of the present disclosure, use of the articles“a” or “an” to modify a noun can be understood to be used forconvenience and to include one, or more than one of the modified noun,unless otherwise specifically stated.

Elements, components, modules, and/or parts thereof that are describedand/or otherwise portrayed through the figures to communicate with, beassociated with, and/or be based on, something else, can be understoodto so communicate, be associated with, and or be based on in a directand/or indirect manner, unless otherwise stipulated herein.

Although the methods and systems have been described relative to aspecific embodiment thereof, they are not so limited. Obviously manymodifications and variations may become apparent in light of the aboveteachings. Many additional changes in the details, materials, andarrangement of parts, herein described and illustrated, can be made bythose skilled in the art. Accordingly, it will be understood that thefollowing are not to be limited to the embodiments disclosed herein, caninclude practices otherwise than specifically described, and are to beinterpreted as broadly as allowed under the law.

1. A method of connecting a first layer of tissue and a second layer oftissue, comprising: providing a loop in a suture to form a loop end;driving at least one of the loop end and a combination of the loop endand an end of the suture on a path through the first layer, into thesecond layer, and back through the first layer; engaging the loop endwith an engaging mechanism located proximate the end of the suture toform a closed ring; tightening the closed ring by drawing the loop endback along the path; and rotating the ring to place the engagingmechanism within the second layer.
 2. A system for connecting a firstlayer of tissue and a second layer of tissue, comprising: a suture; aloop in the suture to form a loop end of the suture; means for drivingat least one of the loop end and a combination of the loop end and anend of the suture on a path through the first layer, into the secondlayer, and back through the first layer; engaging means proximate theend of the suture engaging the loop end to form a closed ring; means fortightening the closed ring by drawing the loop end back along the path;and means for rotating the ring to place the engaging means within thesecond layer.
 3. The method of claim 1, wherein providing, driving,engaging, tightening, and rotating are performed in the order recited.4. The method of claim 1, wherein the first layer of tissue defines alumen on a first side, and the second layer of tissue is located next toanother side of the first layer.